Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours In… (NCT04311489) | Clinical Trial Compass
TerminatedPhase 2
Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide.
Stopped: Interim analysis showing safety concerns
Denmark17 participantsStarted 2020-08-01
Plain-language summary
This clinical trial intends to investigate the safety, tolerability and efficacy of ularitide on the renal response in patients with liver cirrhosis and refractory ascites for a maximum exposure duration of 48 hours, through a randomized, placebo-controlled, double-blind, single-center trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women \>18 years
* Liver cirrhosis confirmed by fibroscan (\>20 kPa), or by imaging with signs of an irregular liver surface with collaterals, or clinically by cirrhosis stigmata
* Refractory ascites Definition: failure to respond to or intolerance to high dose diuretics (spironolactone up to 400mg/day and furosemide up to 160mg/day) and early ascites recurrence (reappearance of grade 2 or 3 ascites within 4 weeks of initial mobilization or ≥2 paracentesis within last 3 months)
* Urine sodium excretion \<60 mmol/24 hour
* Serum creatinine \<150 µmol/L
* Child-Turcotte-Pugh score of B or C (\<13)
* Bilirubin \<150 µmol/L
* Prothrombin time (PP) 0.20-0.60 (INR 1.3-2.5)
* Systolic blood pressure ≥95 mmHg
* Written informed consent to participate in the clinical trial
Exclusion Criteria:
* Gastrointestinal bleeding within 2 weeks prior to inclusion
* Proteinuria \>500 mg/day
* Hemoglobin \<5.5 mmol/L
* Spontaneous bacterial peritonitis within 2 weeks prior to inclusion
* Loculated ascites
* Hepatic encephalopathy grade 2-4 (West-Haven classification)
* Obstructive uropathy
* Primary kidney disease
* Known diagnosis of congestive heart failure
* Known diagnosis of acute-on-chronic liver failure
* Known diagnosis of systemic inflammatory response syndrome
* Acute infections by known diagnosis and/or antibiotic treatment
* Known HIV infection
* Known allergy to the investigational drug or other natriuretic peptides
* Treatment with dobutamine, levosi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute and relative change in sodium excretion rate.
Timeframe: After 24 hours and at termination of treatment (up to 48 hours)
2
Absolute and relative change in urine volume.
Timeframe: After 24 hours and at termination of treatment (up to 48 hours)
3
Change of absolute body weight.
Timeframe: At termination of treatment (up to 48 hours)